FDA Inspection
Presbyterian/St. Luke's Medical Center Donor ServicesPresbyterian/St. Luke's Medical Center Donor Services – FDA Inspection, Aug 23, 2011
Record Details
This FDA Inspection record concerns Presbyterian/St. Luke's Medical Center Donor Services, with an inspection on August 23, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 23, 2011
- Product Type
- Biologics
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ID · b1b45018-f4b0-4cd7-b4aa-c8d6f2cc80f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741768
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
17- 21 CFR 640.21(a)Eligibility of platelet donors
- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.195(a)(1)Temperature and humidity controls
- 21 CFR 1271.200(a)Cleaned, sanitized per established schedules
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 640.61Explanation of hazards
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.25(b)(4)Corrective action
- 21 CFR 640.25(b)Quality control
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Other FDA inspections of Presbyterian/St. Luke's Medical Center Donor Services
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 22, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 26, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 5, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 30, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Presbyterian/St. Luke's Medical Center Donor Services
- FDA Inspection 1233673 - 2024-03-07
- FDA Inspection 1087028 - 2019-04-22
- FDA Inspection 998973 - 2017-01-26
- FDA Inspection 868654 - 2014-03-05
- FDA Inspection 808541 - 2012-11-30
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